Process Engineer II - Fermentation

Facility:  Engineering

Clayton, NC, US

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For nearly 100 years, we have led the way in diabetes care. As a result, our employees embark on life-changing careers with opportunities for mobility and growth within a global organization. At Novo Nordisk, you will work with the best manufacturing professionals in the industry.


Our new Active Pharmaceutical Ingredients (API) facility houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. Are you ready to help make what matters? Then, we are ready for you!


Position Purpose

Ensure successful qualification & execution of the project phases for the Fermentation process, evolving into a process subject matter expert for the Fermentation area.


Main tasks include:

  • Support team in ensuring installed design adheres to process requirements
  • Coordinate & execute process validation activities
  • Provide technical support of the operating facility to meet business goals
  • Coach & mentor less experienced members of the process engineering team



  • Overall validation responsible within area
  • Execute & coordinate all qualification activities included in the project (FAT, SAT, IQ, OQ, PQ)
  • Lead / provide technical support to investigation & resolution of VNC’s & NC’s
  • Support development & implementation of change requests during commissioning & operation
  • Verify process equipment & facilities satisfy design requirements. Ensure designs comply with current pharmaceutical standards applicable for the project such as ASME BPE, GAMP, cGMP, ISPE guidelines
  • Gathering & ensure knowledge transfer to project from DK sponsor site. Support or serve as Process Responsible in Process Groups
  • Support work packages in maintaining schedule & project milestone adherence
  • Ensure coordination & collaboration between project & other site stakeholders
  • Ensure design adheres with process FMECA's & resolve misalignments where observed
  • Develop knowledge of risk assessment documents such as requirements risk assessments (RRA's)
  • Support update, development & design adherence to requirement specification documents
  • Participation in review & update of QRM risk assessments such as closed-system, cross-contamination, contamination & facility flows
  • Apply Fermentation knowledge to the review & update of design documentation (process flow diagrams, P&IDs, etc.)
  • Provide design basis information for accurate process scheduling & capacity calculations
  • Other accountabilities, as assigned


Required Qualifications

  • BA/BS in chemical engineering, biological / biomedical engineering, or other pharmaceutical related field
  • 5-8 years engineering experience in operations, process design/troubleshooting/improvement


Desired Qualifications

  • Six Sigma Green Belt certification or cLEAN® 2-star desired
  • Experience of working with cGMPs & their applications
  • Demonstrated experience in Fermentation processes. Knowledgeable in the following systems:  Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, Root Cause Analysis (RCA), Reliability Centered Maintenance (RCM).
  • Ability to independently apply advanced engineering techniques & analysis within the discipline
  • Strong project management skills
  • Excellent oral & written communication skills
  • Proven expertise in planning/organization/execution of maintenance activities & following up on results
  • Creating &/or revising the work plan for complex problems being resolved by cross functional teams


Physical & Other Requirements

  • Occasionally moves equipment and/or supplies weighing up to 50 pounds within the facility
  • Routinely operates & inspects manufacturing equipment using hands
  • Must be able to be on feet for up to a 12 hour shift
  • Constantly positions oneself to transfer materials within manufacturing environment. Frequently moves about building(s) to access other personnel & operational areas
  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
  • Occasionally ascends/descends a ladder to access service equipment. Works atop elevated positions at heights
  • Occasionally required to secure a motorized vehicle license & operate a motorized vehicle
  • Occasionally works around odorous and/or hazardous materials
  • Occasionally performs critical job functions in extremely cold work environments
  • Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment
  • Able to work in loud noise environments with hearing protection
  • Able to travel internationally, up to 10% of the time
  • Able to work in an open office environment with the possibility of frequent distraction
  • Able to work the hours necessary to support a 24/7 continuous manufacturing operation


We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.


At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.


Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.


If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.